# FDA 483 - PharmaLegacy Research LLC - June 21, 2019

Source: https://www.globalkeysolutions.net/records/483/pharmalegacy-research-llc/458d960c-5b8e-4be8-bbb9-6d1ae8af6ffe

> FDA 483 for PharmaLegacy Research LLC on June 21, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharmaLegacy Research LLC
- Inspection Date: 2019-06-21
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Samm Solutions, Inc. (dba BTS Research) in San Diego, CA, a non-clinical laboratory, revealed significant deficiencies across multiple studies. The firm failed to adhere to study protocols, properly archive raw data, document and authorize deviations, and ensure the accuracy of experimental data. These issues indicate a systemic lack of control and oversight in their GLP-regulated non-clinical laboratory studies.

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## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.globalkeysolutions.net/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)
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Company: https://www.globalkeysolutions.net/companies/pharmalegacy-research-llc/bdd63a11-ccc9-46b9-892e-e7f7548ef0a9

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6